A-Z of Services

A

• Abridged Applications
• Advertising and Promotion Advice
• Agency Meetings
• Annual Safety Reports

B

• Biotechnology Advice, Applications
• Bridging Studies and Reports

C

• Centralised Submissions
• Change of Ownership Submissions
• Clinical Overview
• Clinical Summary
• Clinical Trial Applications (CTA)
• CMC (Chemistry, Manufacturing & Control) Reviews
• Common Technical Document (CTD) Formatting and Converting

D

• Decentralised (DCP) submissions
• Dossier Preparation and Review
• Drug Development Advice
• Due Diligence

E

• eCTD Publishing and Submissions

G

• Gap Analysis
• Generics Application

L

• Line extensions
• License/Marketing Authorisation Maintenance
• Literature Surveillance

M

• Manufacturing Rationalisation (Site Transfers)
• Marketing Authorisation Applications
• Medical Devices
• Mutual Recognition (MRP) Submissions

N

• National Submissions
• NeeS Submissions
• Non-Clinical Overview
• Non-Clinical Summary

O

• On-site Placement & Interim Management
• Orphan Drug Development

P

• Periodic Safety Update Reports (PSUR)
• PIL testing
• Post Marketing Maintenance

Q

• QA/QP Release
• Quality Overall Summary (QOS)

R

• Reclassification (POM - P)
• Regulatory Compliance
• Regulatory Strategy
• Renewals
• Response to Agency Questions

S

• Standard Operating Procedures (SOPs)
• Substantial Amendments to Clinical Trial Applications
• Summary of Product Characteristics (SmPC) Composition

V

• Variations